33 drug samples fail to clear CDSCO test, 2 declared misbranded
New Delhi: In its latest drug safety alert, the apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO), flagged 33 medicine batches for failing to qualify for a random drug sample test for the month of December, while two drug samples have been declared misbranded.
These drug samples which are declared not of standard quality include Mascot Health Serie's Colchicine Tablets I.P. 0.5 mg, Innova Captab's VERMIKIND- 12 (Ivermectin Dispersible Tablets), Stadmed's Disilox MPS (Aluminium, Magnesium and Simethicone Oral Suspension I.P.), Skymap Pharmaceuticals' Trimetazidine Modified Release Tablets 35 mg, SGS Pharmaceutical's Metronidazole Tablets IP (METRONIDAZOLE400), Skymap Pharmaceuticals' Omeprazole GastroResistant Capsules IP 20 mg etc.
In addition, other popular drug samples that are declared not of standard quality include samples from Sun Pharma's Volini pain relief spray containing Diclofenac Diethylamine; Linseed Oil, Methyl Salicylate & Menthol Topical Spray, and GlaxoSmithKline Pharmaceuticals' Betnovate-N Cream containing Betamethasone, Valerate, and Neomycin.
Apart from this, the popular covid drug, Remdesivir For Injection 100 mg/vial (COVIFOR), manufactured by Hetero Labs, is also on the list.
Further, the list contains two misbranded drugs: Primaquine Tablets IP and Diazepam Injection I.P. (Diazelab).
This came after analysis and tests conducted by the CDSCO Drugs Control Department on 1385 samples. Out of these, 1350 samples were found to be of standard quality, while 33 of them were declared as not of standard quality (NSQ), and 2 drugs were declared misbranded.
A few of the reasons why the drug samples tested failed were the failure of the assay, the failure of the dissolution test, the failure of disintegration, and the failure of the identification test.
The samples collected were tested in five laboratories, namely CDL Kolkata, CDTL Mumbai, RDTL Chandigarh, RDTL Guwahati, and CDTL Hyderabad.
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of December – 2021:
Total number of samples tested | 1385 |
Total number of samples declared as of Standard Quality | 1350 |
Total number of samples declared as Not of Standard Quality | 33 |
Total number of samples declared as Spurious | 0 |
Total number of samples declared as Misbranded | 02 |
S.No. | Name of Drugs/medical device/cosmetics | Batch No./Date of Manufacture/Date of Expiry/Manufactured By | Reason for failure | Drawn By | From |
1. | Colchicine 0.5 Tablets (Colchicine Tablets I.P. 0.5 mg) | B. No.: MT201577 Mfg dt: 07/2020 Exp dt: 06/2022 Mfd by: M/s. Mascot Health Series Pvt. Ltd., Plot No. 79, 80, Sector- 6A, IIE, Sidcul, Haridwar -249403 Uttarakhand. | Related Substances | CDSCO, Visakhapatnam | CDL Kolkata |
2. | Tuscure Syrup (Chlorpheniramine, Phenylephrine & Dextromethorphan Syrup), 100 ml | B. No.: ALA2101 Mfg dt: 01/2021 Exp dt: 12/2022 Mfd by: M/s. MMC Healthcare Ltd., No. 34-B, SIDCO Industrial Estate, Thirumazhisai, Chennai -600124. | Assay of Phenylepheri ne Hydrochloride | CDSCO South Zone Chennai | CDL Kolkata |
3. | COVIFOR (Remdesivir For Injection 100 mg/vial) | B. No.: REM121006A Mfg dt: 03/2021 Exp dt: 11/2021 Mfd by: M/s. Hetero Labs Limited, Hyderabad, India, Manufactured At: Aspiro Pharma Limited, Survey No. 321, Biotech Park, Phase-III, Karkapatia Village, Markook Mandal, Siddipet Dist., Telagana State – 502 281, India. | Particulate Matter, Clarity of Solution, Identification and Assay | Sub-Zone Baddi | CDL Kolkata |
4. | VERMIKIND - 12 (Ivermectin Dispersible Tablets) | B. No.: C3FHT015 Mfg dt: 10/2020 Exp dt: 09/2023 Mfd by: M/s. Innova Captab Ltd., 1281/1, Hiltop Industrial Estate, Near EPIP, Phase-1, Jharmajri, Baddi, Distt. Solan, Himachal Pradesh -173205. | Uniformity of Dispersion | CDSCO East Zone Kolkata | CDL Kolkata |
5. | ZINCOPAC BOOST Tablets (Zinc Acetate Tablets 50 mg) | B. No.: APT/04418 Mfg dt: 05/2021 Exp dt: 04/2023 Mfd by: M/s Amkon Pharmaceuticals, Plot No. 242, Phase-9, Industrial Area, Mohali, Punjab -160 062. | Assay of Elemental Zinc | CDSCO East Zone Kolkata | CDL Kolkata |
6. | RESENT (Ondansetron HCl Tablets I.P. 4 mg) | B. No.: 3233 Mfg dt: 06/2021 Exp dt: 05/2023 Mfd by: M/s. Infinitive Pharmaceutical Industries, Plot No.63, G.I.D.C. Industrial Estate, Deesa, Gujarat - 385535. | Dissolution | CDSCO West Zone Mumbai | CDTL Mumbai |
7. | Trypsin Chymotrypsin Tablets | B. No.: MT193963 Mfg dt: 02/2020 Exp dt: 01/2022 Mfd by: M/s. Mascot Health Series Pvt Ltd., Plot No. 79, 80, Sector 6 A, IIE, Sidcul, Haridwar - 249 403 Uttarakhand. | Disintegration test | CDSCO West Zone Mumbai | CDTL Mumbai |
8. | Disilox MPS (Aluminium, Magnesium and Simethicone Oral Suspension I.P.) | B. No.: C22C105 Mfg dt: 06/2021 Exp dt: 05/2024 Mfd by: M/s. Stadmed Private Limited, 15, Jawpore Road, Kolkata 700074. | Microbial contaminatio n in total aerobic viable count and presence of pathogens (E.coli.) | CDSCO Sub-Zone Goa | CDTL Mumbai |
9. | Disilox MPS (Aluminium, Magnesium and | B. No.: C22E106 Mfg dt: 08/2021 Exp dt: 07/2024 | Microbial contaminatio n in total | CDSCO Sub-Zone Goa | CDTL Mumbai |
Simethicone Oral Suspension I.P.) | Mfd by: M/s. Stadmed Private Limited, 15, Jawpore Road, Kolkata 700074. | aerobic viable count | |||
10. | Disilox MPS (Aluminium, Magnesium and Simethicone Oral Suspension I.P.) | B. No.: C22E107 Mfg dt: 08/2021 Exp dt: 07/2024 Mfd by: M/s. Stadmed Private Limited, 15, Jawpore Road, Kolkata 700074. | Microbial contaminatio n in total aerobic viable count and presence of pathogens (E. coli.) | CDSCO Sub-Zone Goa | CDTL Mumbai |
11. | Trimetazidine Modified Release Tablets 35 mg | B. No.: GM21063 Mfg dt: 06/2021 Exp dt: 05/2023 Mfd by: M/s. Skymap Pharmaceuticals Pvt Ltd., B-3, Dev Bhoomi Industrial Estate, Puhana Iqbalpur Road, Roorkee- 247667 Uttarakhand. | Average weight | CDSCO West Zone Mumbai | CDTL Mumbai |
12. | Trimetazidine Modified Release Tablets 35 mg | B. No.: GM20173 Mfg dt: 11/2020 Exp dt: 10/2022 Mfd by: M/s. Skymap Pharmaceuticals Pvt Ltd., B-3, Dev Bhoomi Industrial Estate, Puhana Iqbalpur Road, Roorkee- 247667 Uttarakhand. | Average weight | CDSCO West Zone Mumbai | CDTL Mumbai |
13. | CLODOSPIN B Lotion (Clotrimazole & Beclomethasone Dipropionate Lotion) | B. No.: CS2101 Mfg dt: 04/2021 Exp dt: 03/2023 Mfd by: M/s. Yash Pharma Laboratories Pvt. Ltd., Khasra No. 19-M, Village : Raipur, Pargana : Bhagwanpur, Tehsil : Roorkee, Dist : Haridwar- 247661 Uttarakhand. | Microbial contaminatio n & Assay of Beclomethas one Dipropionate | CDSCO Sub-Zone Goa | CDTL Mumbai |
14. | Themidon (Trimetazidine Dihydrochloride Tablets IP) | B. No.: TDN003 Mfg dt: 07/2020 Exp dt: 06/2023 Mfd by: M/s. Themis | Assay | CDSCO West Zone Mumbai | CDTL Mumbai |
Medicare Limited., Sector 6A, Plot No.16, 17 & 18, IIE, SIDCUL, Haridwar – 249 403, Uttarakhand. | |||||
15. | DICLOFENAC SODIUM TABLETS I.P. 50mg | B. No.: DF11 Mfg dt: 07/2021 Exp dt: 06/2023 Mfd by: M/s. Suzikem Drugs Pvt. Ltd., Plot No. 205/2A, IDA Cherlapalli, Phase II, Medchal Malkajgiri District , Hyderabad- 500051. | Disintegration (Acid Stage) | CDSCO Hyderabad Zone | CDTL Hyderabad |
16. | MECOBALAMIN, FOLIC ACID, ALPHA LIPOIC ACID, PYRIDOXINE HCI & THIAMINE HCI TABLETS (COBAL® FORTE) | B. No.: BM3002 Mfg dt: 09/2020 Exp dt: 08/2022 Mfd by: M/s. Bio Neutraceuticals, 8- 290/1, Groud Floor, Goutham Nagar, Ferozguda, Secunderabad - 500011, Telangana. | Disintegration and Assay of Mecobalamin , Alpha Lipoic Acid and Thiamine Hydrochloride | CDSCO Hyderabad Zone | CDTL Hyderabad |
17. | (PANTOPRAZOLE FOR INJECTION BP 40 MG) | B. No.: AA010102 Mfg dt: 05/2020 Exp dt: 04/2022 Mfd by: M/s. ANG Lifesciences India Ltd. Village: Kishanpura, Nalagarh Road, Tehsil: Baddi, Distt: Solan, Himachal Pradesh - 174101. | Particulate matter | Drug Control Department Delhi | RDTL Chandigarh |
18. | Cefpodoxime Proxetil Dispersible Tablets 200 mg (POME 200 TABLETS) | B. No.: WJT-175J Mfg dt: 08/2021 Exp dt: 07/2023 Mfd by: M/s. WELCURE REMEDIES Nahan Road, Vill.Moginand, Distt. Sirmour-173030 Himachal Pradesh. | Disintegration Test | CDSCO Sub - Zone Baddi | RDTL Chandigarh |
19. | Betamethasone Valerate and | B. No.: FC989 | Identification | Drug Control Department | RDTL Chandigarh |
Neomycin Skin Cream (BETNOVATE-N CREAM) | Mfg dt: 05/2021 Exp dt: 10/2022 Mfd by: M/s. GlaxoSmithKline Pharmaceuticals Limited At: Plot No. C- 1, Madkaim Industrial Estate, Madkaim, Post-Mardol, Ponda, Goa 403404. | Delhi | |||
20. | Diclofenac Diethylamine; Linseed Oil; Methyl Salicylate & Menthol Topical Spray (VOLINI PAIN RELIEF SPRAY) | B. No.: XDY0036 Mfg dt: 08/2021 Exp dt: 07/2023 Mfd by: M/s sun pharmaceutical ind.ltd. At: V.P.O.Bathu, Teh. Haroli. Himachal Pradesh, Dist. Una- 174301. | Identification (Negative for Diclofenac Diethylamine and Linseed oil) and Assay of Methyl Salicylate, Menthol. | Drug Control Department Delhi | RDTL Chandigarh |
21. | (ZINC SULPHATE DISPERSIBLE TABLETS IP) | B. No.: ZST21024 Mfg dt: 07/2021 Exp dt: 06/2023 Mfd by: M/s. LA- CHEMICO PRIVATE LIMITED Taki Road Kadambagachi, Barasat, North 24- Parganas, West Bengal, Kolkata- 700125, West Bengal. | Disintegration Test | CDSCO Sub Zone Jammu | RDTL Chandigarh |
22. | Acebrophylline (SR), Fexofenadine Hydrochloride and Montelukast Sodium Tablets (LEVOICE-3D TABLETS) | B. No.: T21G522D Mfg dt: 07/2021 Exp dt: 06/2023 Mfd by: M/s. Bajaj Formulations Khasra No. 161, Village Lakeshwary, Bhagwanpur, Roorkee, distt. Haridwar Uttarakhand. | Assay of Montelukast Sodium calculated as Montelukast | Drug Control Department Srinagar | RDTL Chandigarh |
23. | COLGATE DENTAL CREAM ANTICAVITY TOOTHPASTE | B. No.: B19 Mfg dt: 06/2021 Exp dt: 05/2023 Mfd by: M/s. COLGATE- PALMOLIVE (INDIA) | Appearance, Dispensing, Particle feel on butter paper, Total Microbial Count, Total | Drug Control Department Delhi | RDTL Chandigarh |
LIMITED Code IN12 Address Not Mentioned. | Yeast and Mould Count | ||||
24. | DROTAVERINE HYDROCHLORIDE IP | B. No.: DTV/170/2021 Mfg dt: 10/2021 Exp dt: 09/2026 Mfd by: M/s. Punjab Chemical & Crop Protection Limited Village: Koli Majra, Samalher, P.O.-Lalru, Distt. SAS Nagar, (Mohali) Punjab, INDIA. | Loss on Drying | CDSCO Sub-Zone Guwahati | RDTL Chandigarh |
25. | Trypsin, Bromelain & Rutoside Trihydrate Tablets | B. No.: GT200466 Mfg dt: 03/2020 Exp dt: 02/2022 Mfd by: M/s. Theon Pharmaceuticals Ltd. Vill. Saini Majra,Teh. Nalagarh, Distt. Solan Himachal Pradesh - 174101. | Description | CDSCO Sub-Zone | RDTL Guwahati |
26. | Pantoprazole Gastro Resistant Tablets IP | B. No.: TD20-16 Mfg dt: 04/2020 Exp dt: 03/2022 Mfd by: M/s. Om Biomedic Pvt Ltd, Plot No. 68, 69, 82 & 83, Sector-6A, IIE, SIDCUL, Haridwar– 249403 Uttarakhand. | Dissolution (Buffer stage) | Drug Control Department Assam | RDTL Guwahati |
27. | Metronidazole Tablets IP (METRONIDAZOLE- 400) | B. No.: TMRL-036 Mfg dt: 12/2020 Exp dt: 11/2023 Mfd by: M/s. SGS PHARMACEUTICAL (P) LTD. E-13/1, Sec- 17, Kavi Nagar, Indl. Area, Ghaziabad – 201002, Uttar Pradesh. | Dissolution | Drug Control Department Jharkhand | RDTL Guwahati |
28. | Diazepam Injection I.P. (Diazelab) | B. No.: KDZI-001 Mfg dt: 02/2020 Exp dt: 01/2022 | Misbranded | Drug Control Department Bihar | RDTL Guwahati |
Mfd by: M/s. Laborate Pharmaceutical India Ltd, (Unit-II) #31, Rajban Road, Nariwala, Paonta Sahib, Himachal Pradesh. | |||||
29. | Ciprofloxacin Tablets I.P. 500 mg. (Cipronir-500) | B. No.: CCF912011 Mfg dt: 12/2019 Exp dt: 11/2022 Mfd by: M/s. Celebrity Biopharma Ltd. Village- Panga, Via – Jharmajri, Hill Top Estate, Barotiwala, Dist. – Solan, Himachal .Pradesh - 174103. | Dissolution | Drug Control Department Jharkhand | RDTL Guwahati |
30. | Telmisartan Tablets IP 40 mg | B. No.: TETY-01 Mfg dt: 04/2021 Exp dt: 03/2023 Mfd by: M/s. NESTOR PHARMACEUTICALS LIMITED, 11, Western Extension Area, Faridabad-121001, Haryana INDIA. | Dissolution | Drug Control Department Jharkhand | RDTL Guwahati |
31. | Dexamethasone Sodium Phosphate Injection IP | B. No.: I-131 Mfg dt: 04/2021 Exp dt: 03/2023 Mfd by: M/s. Jackson Laboratories Pvt. Ltd. 22-24, Majitha Road, Bye pass, Amritsar- 143001,Punjab (India). | Assay | Drug Control Department Jharkhand | RDTL Guwahati |
32. | Omeprazole Gastro- Resistant Capsules IP 20 mg | B. No.: GM20126 Mfg dt: 11/2020 Exp dt: 10/2022 Mfd by: M/s. Skymap Pharmaceuticals Pvt. Ltd., B-3, Dev Bhoomi Industrial Estate, Puhana, Iqbalpur road, Roorkee – 247667 Uttarakhand. | Dissolution | CDSCO Sub-Zone Guwahati | RDTL Guwahati |
33. | Omeprazole Capsule I.P. 20 mg. | B. No.: SBC-20/021 Mfg dt: 03/2020 | Dissolution | Drug Control Department Jharkhand | RDTL Guwahati |
Exp dt: 02/2022 Mfd by: M/s. Supercure Biotech Private Limited, Plot No. 99/4/1, Friends Colony, G.T. Road, Kundali, Haryana-131028 (India). | |||||
34. | Primaquine Tablets IP | B. No.: AHT-2769 Mfg dt: 10/2021 Exp dt: 09/2023 Mfd by: M/s. Not readable/not visible/not appeared in a conspicuous manner on the label. | Misbranded | CDSCO Sub-Zone Guwahati | RDTL Guwahati |
35. | Ciprofloxacin Hydrochloride Tablets I.P. 500 mg. | B. No.: 0702420 Mfg dt: 06/2020 Exp dt: 05/2023 Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Limited, (A Govt. of India Enterprise) Plot no. 14, II Phase, Peenya, Bengaluru- 560058, Karnataka. | Dissolution | Drug Control Department Jharkhand | RDTL Guwahati |
Also Read:42 drug samples fail to qualify CDSCO test, 1 declared misbranded
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